FemaSeed Intratubal Insemination
FDA 510(k) K231730 · Femasys, Inc.
510(k) numberK231730
Submission
- Device name
- FemaSeed Intratubal Insemination
- Applicant
- Femasys, Inc.
Suwanee, GA, US - Received
- June 13, 2023
- Decision date
- September 22, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQF – Catheter, Assisted Reproduction
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.6110
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code MQF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253354 | Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C…MQF · Traditional | Guangzhou Hehong Biotech Co., Ltd. | 02/12/2026SE |
| K243373 | Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter -…MQF · Traditional | Vitrolife Sweden AB | 07/23/2025SE |
| K240307 | VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)MQF · Traditional | Shenzhen Vitavitro Biotech Co., Ltd. | 08/16/2024SE |
| K220010 | Daylily Single Use Sterile Embryo Transfer CatheterMQF · Traditional | Shanghai Horizon Medical Technology Co., Ltd. | 12/16/2022SE |
| K200248 | Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft ObturatorsMQF · Traditional | Allwin Medical Devices, Inc. | 07/01/2020SE |
| K192540 | Kitazato ET CathetersMQF · Traditional | Kitazato Corporation | 05/01/2020SE |
| K190522 | Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra…MQF · Traditional | Allwin Medical Devices, Inc. | 11/14/2019SE |
| K191015 | Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter…MQF · Special | Cook Incorporated | 05/17/2019SE |
| K180302 | Guardia Access Malleable Obturator, Guardia Obturator, Soft-Pass Obturator…MQF · Traditional | Cook Incorporated | 10/24/2018SE |
| K173431 | Towako Transmyometrial Embryo Transfer SetMQF · Special | William A. Cook Australia Pty. , Ltd. | 05/18/2018SE |
More from William A. Cook Australia Pty. , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K253403 | FemVue® Controlled Saline-Air Device (FSA-300)LKF · Traditional | 12/15/2025SE |
| K242002 | FemVue MINI Saline-Air DeviceLKF · Traditional | 11/22/2024SE |
| K241693 | FemChec Controlled Saline-Air Device (FCD-250)LKF · Traditional | 09/06/2024SE |
| K122658 | Femcerv Endocervical Sampler Model 3 Sizes: Ref FCV-013, Ref FCV-011, Ref FCV-009PCF · Traditional | 12/20/2012SE |
| K110993 | Femchec Pressure Managemet DeviceLKF · Traditional | 10/12/2011SE |
| K110288 | Femvue Saline-Air DeviceLKF · Traditional | 04/28/2011SE |
| K100662 | Femvue Cornual Balloon CatheterLKF · Special | 04/07/2010SE |
| K083690 | Femvue(Tm) Catheter SystemLKF · Traditional | 06/23/2009SE |
Questions and answers
When was FemaSeed Intratubal Insemination cleared by the FDA?
FemaSeed Intratubal Insemination (K231730) received a 510(k) decision of Substantially Equivalent on September 22, 2023, 101 days after the submission was received.
What is the product code of K231730?
The FDA product code is MQF – Catheter, Assisted Reproduction, a Class II (moderate risk) device regulated under 21 CFR 884.6110.